Phase 3 trial of Novavax investigational COVID-19 vaccine opens

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.Novavax launched a Phase 3 clinicaltrial for COVID19 vaccine candidate NVX-CoV2373 funded by NIH & BARDA. The investigational vaccine uses a stabilized form of the coronavirus spike protein (which cannot replicate) to induce an immune response.

. The CoVPN includes existing NIAID-supported clinical research networks with infectious disease expertise and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for preventing COVID-19.

“We’ve come this far, this fast, but we need to get to the finish line,” said NIH Director Francis S. Collins, M.D., Ph.D. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.” Participants will be followed closely for potential vaccine side effects and will be asked to provide blood samples at specified time points after each injection and during the following two years. Scientists will analyze the blood samples to detect and quantify immune responses to SARS-CoV-2, the virus that causes COVID-19. Of note, specialized assays will be used to distinguish between immunity as a result of natural infection and vaccine-induced immunity.

 

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